Special Warning : אזהרת שימוש

4.4   Special warnings and precautions for use
If hypersensitivity reactions occur, the administration of the medicinal product must be discontinued immediately and, if necessary, intravenous treatment initiated. Resuscitative medicinal products and equipment (e.g endotracheal tube and ventilator) have to be readily available.
This radiopharmaceutical may be received, used and administered only by authorised persons in designated clinical settings. Its receipt, storage, use, transfer and disposal are subject to the regulations and the appropriate licences of the local competent official organisations.
For each patient, exposure to ionising radiation must be justifiable on the basis of likely benefit. The activity administered must be such that the resulting dose is as low as reasonably achievable bearing in mind the need to obtain the intended diagnostic result.
The patient should be well hydrated before and after the examination and urged to void as often as possible during the first 48 hours after the procedure in order to minimise radiation exposure.
Formal studies have not been carried out in patients with significant renal or hepatic impairment. In the absence of data, DaTSCAN is not recommended in cases of moderate to severe renal or hepatic impairment.
This medicinal product contains 39.5 g/l (5% volume) ethanol (alcohol), up to 197 mg per dose, equivalent to 5 ml beer or 2 ml wine. Harmful for those suffering from alcoholism. To be taken into account in high-risk groups such as patients with liver disease or epilepsy.

Interpretation of DaTSCAN Images
DaTSCAN images are interpreted visually, based upon the appearance of the striata.
Optimum presentation of the reconstructed images for visual interpretation is transaxial slices parallel to the anterior commissure-posterior commissure (AC-PC) line. Determination of whether an image is normal or abnormal is made by assessing the extent (as indicated by shape) and intensity (in relation to the background) of the striatal signal.
Normal images are characterised by two symmetrical crescent-shaped areas of equal intensity.
Abnormal images are either asymmetric or symmetric with unequal or reduced intensity and/or loss of crescent.
As an adjunct, visual interpretation may be assisted by semi-quantitative assessment using CE-marked software, where DaTSCAN uptake in the striatum is compared with uptake in a reference region and ratios are compared against an age adjusted healthy subjects’ database. The evaluation of ratios, such as the left/right striatum DaTSCAN uptake (symmetry) or caudate/putamen uptake, may further help with the image assessment.
The following precautions should be taken when using semi-quantitative methods: • Semi-quantification should only be used an adjunct to visual assessment • Only CE marked software should be used
• Users should be trained in the use of CE marked software by the manufacturer and follow EANM practice guidelines for image acquisition, reconstruction and assessment • Readers should interpret the scan visually and then perform the semi-quantitative analysis according to manufacturer’s instructions including quality checks for the quantitation process o ROI /VOI techniques should be used to compare uptake in the striatum with uptake in a reference region o Comparison against an age adjusted healthy subjects database is recommended to account for age-expected decrease in striatal binding o The reconstruction and filter settings (including attenuation correction) used can affect the semi-quantitative values. The reconstruction and filter settings recommended by the manufacturer of the CE marked software should be followed and should match those used for semi-quantification of the healthy subjects database.
o The intensity of the striatal signal as measured by SBR (striatal binding ratio) and asymmetry and caudate to putamen ratio provide objective numerical values corresponding to the visual assessment parameters and can be helpful in difficult to read cases o If the semi-quantitative values are inconsistent with the visual interpretation, the scan should be evaluated for appropriate placement of the ROIs /VOIs, correct image orientation and appropriate parameters for image acquisition and attenuation correction should be verified. Some software packages can support these processes to reduce operator-dependent variability o Final assessment should always consider both visual appearance and semi-quantitative results

Effects on Driving

4.7   Effects on ability to drive and use machines
DaTSCAN has no known influence on the ability to drive and use machines.